Participating
OrganizationsCenters for Disease Control and Prevention (CDC) at http://www.cdc.gov/

Components of
Participating OrganizationsNational Center for Injury
Prevention and Control (NCIPC/CDC) at http://www.cdc.gov/ncipc/

Title: Research for Preventing Violence and Violence
–Related Injury (R01)

The
policies, guidelines, terms, and conditions of the HHS Centers for Disease
Control and Prevention (CDC) stated in this announcement might differ from
those used by the HHS National Institutes of Health (NIH).

If
written guidance for completing this application is not available on the CDC
website, then CDC will direct applicants elsewhere for that information.

Authority:This program is authorized under Section 301 (a)
[42 U.S.C. 241(a)] of the Public Health Service Act, and Section 391 (a)[42
U.S.C. 280 b(a)] of the Public Health Service Act, as amended

Announcement
Type:New

Instructions for Submission of Electronic
Research Applications:

If you do not have access to the Internet, or if
you have difficulty accessing the forms online, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGOTIMS) staff. For this, or further assistance, contact PGO TIMS: Telephone
(770) 488-2700, Email: PGOTIM@cdc.gov.

NOTICE: Applications submitted in response
to this Funding Opportunity Announcement (FOA) for Federal assistance must be
submitted electronically through Grants.gov (http://www.grants.gov) using the SF424
Research and Related (R&R) forms and the SF424 (R&R) Application
Guide.

This FOA
must be read in conjunction with the application package instructions included
with this announcement on Grants.gov/Apply for Grants (hereafter referred to as,
Grants.gov/Apply.)

A
registration process is necessary before submission, and applicants are
strongly encouraged to start the process at least four weeks prior to the grant
submission date. See Section IV.

Two
steps are required for on time submission:

1) The
application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Standard Timeon
the application submission receipt date (see “Key Dates” below.)

2)
Applicants must complete a verification step in the Electronic Research
Administration (eRA Commons) within two business days of
notification. Note: Since email can be unreliable, it is the responsibility of
the applicant to periodically check on their application status in the eRA Commons.

Funding
Opportunity Announcement (FOA) Number:RFA-CE-08-003

Catalog of Federal Domestic Assistance Number(s):93.136

Key DatesRelease/Posted
Date: December 19, 2007Letter of Intent Receipt Date: January 17, 2008Application Submission Receipt Date(s): February 15, 2008Peer Review Date(s):March
- April, 2008Council Review Date(s):May
- June, 2008Earliest
Anticipated Start Date(s):September, 2008Additional
Information to Be Available Date: Technical
assistance will be available for potential applicants during one conference
call. The call for eligible applicants will be held on January 15, 2008 from
9:30 a.m. to 11:00 a.m. (Eastern Time). The conference can be accessed by
calling: 1-866-704-7564, stating the leader name: Ms Lady Patterson, and
entering the passcode: 1314492.Expiration
Date:February 16, 2008

Due
Date for E.O. 12372

Executive Order 12372 does not apply to this program.

Additional
Overview Content

Executive Summary

NCIPC is soliciting investigator-initiated (R01)
research that will expand and advance the understanding of violence, its
causes, and prevention strategies. Applications must address one of the
research objectives listed in this FOA.

The participating organizations intend to commit a total
of $1.8 million to this RFA for
payment of applications responsive to this announcement statement.

Awards issued under this FOA are contingent upon the
availability of funds and the submission of a sufficient number of
meritorious applications.

Five to six awards will be funded

Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the size
and duration of each award will also vary. The total amount awarded and
the number of awards will depend upon the activity code, quality,
duration, and costs of the applications received.

Budget Period, Project Period, and
Award Amounts: The budget period will be
for one year and the anticipated project period up to three years. The
funding level will not exceed $300,000 total (including direct and
indirect costs) per year.

Eligible Organizations:Public
nonprofit organizations; private nonprofit organizations; for profit
organizations; small, minority, and women-owned businesses; universities;
colleges; research institutions; hospitals; community-based organizations;
faith-based organizations; federally recognized or state-recognized
American Indian/Alaska Native tribal governments; American Indian/Alaska
Native tribally designated organizations; Alaska Native health
corporations; urban Indian health organizations; tribal epidemiology
centers; state and local governments or their Bona Fide Agents (this
includes the District of Columbia, the Commonwealth of Puerto Rico, the
Virgin Islands, the Commonwealth of the Northern Marianna Islands,
American Samoa, Guam, the Federated States of Micronesia, the Republic of
the Marshall Islands, and the Republic of Palau); and political
subdivisions of states (in consultation with states.) A Bona Fide Agent is an agency/organization identified by
the state as eligible to submit an application under the state
eligibility in lieu of a state application. If you are applying as a bona
fide agent of a state or local government, you must provide required
documentation from the state or local government as documentation of your
status. Attach this documentation behind the first page of your
application form or for electronic applications, use a PDF file and attach
as “Other Documents” and label as appropriate.

The National Center for Injury Prevention and Control of CDC within HHS is
committed to achieving the health promotion and disease prevention objectives
of "Healthy People 2010" and to measuring program performance as
stipulated by the Government Performance and Review Act (GPRA). This RFA
addresses “Healthy People 2010” priority area(s) of injury and violence prevention and is in alignment with NCIPC performance goal(s) to conduct
a targeted program of research to reduce injury-related disability. ) For more information, see www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/.

The purposes of the NCIPC extramural research program are
to:

Build the scientific base for the prevention and control
of fatal and nonfatal injuries and related disabilities.

Encourage professionals from a wide spectrum of disciplines
of epidemiology, behavioral and social sciences, medicine, biostatistics,
public health, health economics, law, criminal justice, and engineering to
perform research in order to prevent and control injuries more effectively.

Encourage investigators to propose research that
involves intervention development and testing as well as research on methods to
enhance the adoption and maintenance of effective intervention strategies among
individuals, organizations, or communities.

Research Objectives

NCIPC is soliciting investigator-initiated research that
will help expand and advance our understanding of violence, its causes, and
prevention strategies. The following research objectives are the focus of this
solicitation:

1. Dissemination/Implementation Research

Conduct studies aimed at identifying and evaluating
efficient and effective methods for the dissemination and implementation of
evidence-based interventions, programs, and polices to prevent either the
perpetration of or victimization from violence. This research is intended to
bridge the gap between prevention research and everyday practice by building a
knowledge base about how evidence-based violence prevention information and
strategies are disseminated, translated and integrated for use by communities
and policy makers. Examples of such studies include: examining the optimal ways
to synthesize, translate, and package effective prevention approaches;
examining ways to build individual and organizational capacities to use
effective approaches (i.e., understanding the type and quality of technical
assistance – training, coaching, monitoring – necessary to support effective
implementation); understanding how individual, organizational and community
characteristics influence the adoption and effective use of
empirically-supported violence prevention approaches; and once an effective
approach is adopted, understanding the effects of implementing the program,
policy, or practice as originally developed (i.e., with “fidelity”), as opposed
to changing the content or delivery format (i.e., “adapting”). While adaptation
occurs with great frequency in the practice field, we know very little about
the kinds of modifications that are likely to diminish or increase an
intervention’s effectiveness.

For this solicitation, funds are available to address
dissemination/implementation research in the areas of child maltreatment or
youth violence. Evidence-based interventions, programs, and policies are
defined as those for which there is evidence of effectiveness in reducing
perpetration of or victimization from child maltreatment or youth violence
based on systematic reviews of the field or two or more well designed studies
(i.e., experimental, quasi-experimental, time series, or similar designs with
appropriate baseline/pre-intervention data, post-intervention data and
comparison or control groups).

For this solicitation, funds are available to conduct such
studies aimed at preventing the perpetration of child maltreatment, intimate
partner violence, sexual violence, youth violence, and/or suicidal behavior.
There is particular interest in evaluating approaches that make changes at the
family/relationship, community or societal levels of social influence; in
evaluating approaches designed to reduce multiple forms of violence; and in
approaches aimed at reducing racial/ethnic, gender, and/or economic
disparities.

3. Etiologic Research

Conduct studies to examine the development of perpetration.
These studies should be designed to provide a better understanding of the
developmental pathways and social circumstances that contribute to the
perpetration of violence. Such studies should be designed to provide important
information on the populations at high-risk for perpetration, the modifiable
risk and protective factors, as well as the optimal developmental periods and
settings for intervention.

For this solicitation, funds are available to examine the
development of perpetration in the areas of suicidal behavior, intimate partner
violence, sexual violence, and/or child maltreatment.

A detailed categorical
budget for the “Initial budget Period” and the “Entire Proposed Period of
Support” must be submitted with the application.

2. Funds Available

The participating
Centers, Institutes, and Offices (CIOs) (NCIPC) intend to commit
approximately $1.8 million (direct and indirect cost) dollars in FY2008to fund5 to 6applications. The average award amount will
be up to $300,000 total (direct and indirect costs) for the first 12-month
budget period. An applicant may request
a project period of up to 3 years. An
applicant may request up to $300,000 maximum
for the first 12-month budget period. The approximate total project
period funded amount is $900,000. The
anticipated start date for new awards is September,
2008.

All estimated funding amounts are subject to
availability of funds.

If an applicant requests a funding amount greater than the
ceiling of the award range, HHS/CDC will consider the application
non-responsive, and it will not enter into the review process. HHS/CDC will
notify the applicant that the application did not meet the submission
requirements.

Because the nature and scope of the proposed research will
vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of the CIO
(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.

Section
III. Eligibility Information

1. Eligible
Applicants

1.A.
Eligible Institutions

You may submit an
application if your organization has any of the following characteristics:

State and local governments or their Bona Fide Agents
(this includes the District of Columbia, the Commonwealth of Puerto Rico,
the Virgin Islands, the Commonwealth of the Northern Marianna Islands,
American Samoa, Guam, the Federated States of Micronesia, the Republic of
the Marshall Islands, and the Republic of Palau)

Political subdivisions of States (in consultation with
States)

A Bona Fide Agent is an
agency/organization identified by the state as eligible to submit an
application under the state eligibility in lieu of a state application.
If you are applying as a bona fide agent of a state or local government, you
must provide a letter from the state or local government as documentation of
your status. Attach this documentation behind the first page of your
application form or for electronic applications, use a .pdf file and attach as
“Other Documents” and label as appropriate.

To be considered responsive to this announcement, the
applicant institution must provide:

Documentation that the institutions principal
investigator (s) and project team have prior experience in conducting violence
prevention research in the chosen priority area (e.g.,
dissemination/implementation research, efficacy/effectiveness research,
etiologic research in violence). This must be evidenced by first-authored
peer-reviewed publications in the chosen priority area, or experience as the
Principal Investigator or Co-Investigator of a current or previous research
grant in the chosen priority area. Applicant should clearly identify the relevant
publications or grant support.

Documentation of effective and well-defined
working relationships with any organization and/or outside entities expected to
participate in the proposed research that will ensure implementation of the
proposed activities. This should be evidenced by letters of support detailing
the nature and extent of the involvement from the performing organization and
outside entities (include in the appendices).

The overall match between the proposed theme and
research objectives and the program priorities as described under the heading
“Research Objectives”. In addition:

For priority 1, the institution
should provide documentation that the proposed research plan for an
evidence-based intervention, program, or policy chosen for this priority
(dissemination/implementation research in either the area of child maltreatment
or youth violence) has been previously evaluated and demonstrated effective for
the outcome of interest. Include in the appendices, published results from at
least two or more well-designed studies showing evidence of effectiveness, or a
systematic review of the field (e.g., Cochrane Review, Blueprints for Violence
Prevention Task Force on Community Preventive Services) that identifies the
intervention, program, or policy as effective.

For priority 2 (efficacy/effectiveness
research), only proposals that evaluate a strategy, program, or policy that is
focused on primary, not secondary prevention of perpetration of violence, and
focuses on a target population that has not already engaged in the perpetration
of violence will be considered responsive to the objectives of the FOA.

For priority 3 (etiologic research), only
applications that propose to examine the development of perpetration in the
areas of interest for this solicitation will be considered responsive.

An
applicant institution can submit more than one application in response to this
FOA, but may not submit more than one application with the same principal
investigator. Accepted applications will remain active for one year from the
receipt date. Applicants may not submit a revised or amended application for
subsequent receipt dates, but may submit a previously reviewed, unfunded
submission as a new application that will compete with other submitted
applications.

If your
application is incomplete or non-responsive to the special requirements listed
in this section, it will not be entered into the review process.

Note: Title 2 of
the United States Code Section 1611 states that an organization described in
Section 501(c)(4) of the Internal Revenue Code that engages in lobbying
activities is not eligible to receive Federal funds constituting an award,
grant, or loan.

Section IV. Application and Submission Information

To download a SF424
(R&R) Application Package and SF424 (R&R) Application Instructions for
completing the SF424 (R&R) forms for this FOA, link to Grants.gov/Apply and follow the
directions provided on that Web site.

A one-time registration is
required for institutions/organizations at the following:

IMPORTANT: both the
applicant organization, as well as the PD/PI must register in eRA Commons for
an application to be accepted electronically. The Credentials Log-In,
referenced in Section IV. 2. Content and Form of Application Submission, is
obtained through Step #3 in the required actions below.

PD/PIs should work with
their institutions/organizations to make sure they are registered in the eRA
Commons.

The following three steps
are required before an applicant institution/organization can submit an
electronic application, as follows:

If your organization does not have
a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN),
allow for extra time. A valid TIN or EIN is necessary for CCR registration.

The CCR also validates the EIN
against Internal Revenue Service records, a step that will take an additional
one to two business days.

If Foreign Institutions are listed
in Section III.1.A. Eligible Institutions, include the following bullet:
Applicants outside the US are required to include a NATO Commercial and
Government Entity (NCAGE) number on their CCR registration. See section IV.2.
Content and Form of Application Submission, for instructions.

The individual designated as the PD/PI on the
application must also be registered in the eRA Commons. It is not
necessary for PDs/PIs to register with Grants.gov.

The PD/PI must hold a PD/PI account in the eRA Commons
and must be affiliated with the applicant organization. This account
cannot have any other role attached to it other than the PD/PI.

This registration/affiliation must be done by the
Authorized Organization Representative/Signing Official (AOR/SO) or their
designee who is already registered in the eRA Commons.

Both the PD/PI and AOR/SO need separate accounts in the
eRA Commons since both hold different roles for authorization and to view
the application process.

Note that if a PD/PI is
also an HHS peer-reviewer with an Individual DUNS and CCR registration, that
particular DUNS number and CCR registration are for the individual reviewer
only. These are different than any DUNS number and CCR registration used by an
applicant organization. Individual DUNS and CCR registration should be used only
for the purposes of personal reimbursement and should not be used on any grant
applications submitted to the Federal Government.

Several of the steps of the
registration process could take four weeks or more. Therefore, applicants
should immediately check with their business official to determine whether
their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly
encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs
complete all necessary registrations.

1.
Request Application Information

Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA) although some of the "Attachment" files may
be useable for more than one FOA.

If you do not have access to the Internet, or if
you have difficulty accessing the forms online, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGOTIMS) staff. For this, or further assistance, contact PGO TIMS: Telephone
(770) 488-2700, Email: PGOTIM@cdc.gov.

Prepare all
applications using the SF424 (R&R) application forms and in accordance with
the SF424 (R&R) Application Guide (MS
Word or PDF).

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to HHS/CDC. There are fields within the SF424 (R&R) application components
that, although not marked as mandatory, are required by HHS/CDC (e.g., the
“Credential” log-in field of the “Research & Related Senior/Key Person
Profile” component must contain the PD/PI assigned eRA Commons User ID).
Agency-specific instructions for such fields are clearly identified in the
Application Guide. For additional information, see “Tips and Tools for
Navigating Electronic Submission” on the front page of “Electronic Submission of Grant
Applications.”

The SF424 (R&R)
application is comprised of data arranged in separate components. Some
components are required, others are optional. The forms package associated with
this FOA in Grants.gov/APPLYwill
include all applicable components, mandatory and optional. A completed
application in response to this FOA will include the following components:

Prospective applicants are asked to submit a letter of intent
that includes the following information:

Descriptive
title of proposed research.

Name, address,
and telephone number of the Principal Investigator.

Names of other
key personnel.

Participating
institutions.

Number and title
of this funding opportunity

Although a
letter of intent is not required, is not binding, and does not enter into the review
of a subsequent application, the information that it contains allows CDC
Program staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed
in Section IV.3.A

If the instructions in this announcement differ in any
way from the SF424 R&R instructions, follow the instructions in this
announcement.

To submit an application in response to this FOA, applicants
should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically
through Grants.gov (http://www.grants.gov),
the application will be electronically time/date stamped by Grants.gov. The
applicants’ Authorized Organization Representative (AOR) will receive an e-mail
notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the
application.

All requested information must be received in the HHS/CDC
Procurement and Grants Office by 5:00 p.m. Eastern Standard Time on the
deadline date. If an applicant submits materials by the United States Postal Service
or commercial delivery service, you must ensure that the carrier will be able
to guarantee delivery by the closing date and time. If HHS/CDC receives your
submission after closing because of : (1) carrier error, when the carrier
accepted the package with a guarantee for delivery by the closing date and
time, or (2) significant weather delays or natural disasters, you have the
opportunity to submit documentation of the carrier’s guarantee. If the
documentation verifies a carrier problem, HHS/CDC will consider the submission
as having been received by the deadline.

This
announcement is the definitive guide on Letter Of Intent (LOI) and application
content, submission address, and deadline. It supersedes information provided
in the application instructions. If your application does not meet the
deadline described in Section IV.3.A, it will not be
eligible for review, and HHS/CDC will discard it. You will receive notification
that you did not meet the submission requirements.

Otherwise, HHS/CDC will not notify you upon receipt of
your paper submission. If you have a question about the receipt of your
application, first contact your courier. If you still have a question, contact
the PGO-TIMS staff at: 770-488-2700. Before calling, please wait two to three
days after the submission deadline. This will allow time for HHS/CDC to
process and log submissions.

If submitting a paper application, it must be prepared
using the 424 R&R instructions for preparing a research grant application.
Submit a signed, typewritten original of the application and all appendices, including
the checklist, and three signed photocopy(s) to the following address:

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Standard Time
on the application submission date(s) described above (Section IV.3.A.). If HHS/CDC receives an application
after that submission date and time, the application may be delayed in the
review process or not reviewed.

Once an application
package has been successfully submitted through Grants.gov, any errors have
been addressed, and the assembled application has been created in the eRA
Commons, the PD/PI and the Authorized Organization Representative/Signing
Official (AOR/SO) have two business days to view the application image.

If
everything is acceptable, no further action is necessary. The application will
automatically move forward for processing by the CDC, PGO, Technical
Information Management Section, after two business days.

Prior
to the submission deadline, the AOR/SO can “Reject” the assembled application
and submit a changed/corrected application within the two day viewing window.
This option should be used if the AOR/SO determines that warnings should be
addressed. Reminder: warnings do not stop further application processing. If an
application submission results in warnings (but no errors) it will
automatically move forward after two business days if no action is taken.
Please remember that some warnings may not be applicable or may need to be
addressed after application submission.

If
the two day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn’t
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course
of action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted but it will be subject to
the CDC late policy guidelines and may not be accepted. The reason for this
delay should be explained in the cover letter attachment
and must refer only to Commons errors and/or technical errors.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two days.

Upon
receipt, applications will be evaluated for completeness and responsiveness by NCIPC and HHS/CDC Procurement and Grants
Office (PGO). HHS/CDC will not review incomplete and
non-responsive applications.

There
will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons.

The HHS/CDC will not accept any
application in response to this FOA that is essentially the same as one
currently pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application, originally
submitted as an investigator-initiated application, is to be submitted in
response to a funding opportunity, it is to be prepared as a NEW application.
That is, the application for the funding opportunity must not include an
Introduction describing the changes and improvements made, and the text must
not be marked to indicate the changes from the previous unfunded version of the
application.

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

All HHS/CDC
awards are subject to the terms and conditions, cost principles, and other
considerations described in the HHS Grants Policy Statement.

Restrictions, which applicants must
take into account while writing their budgets, are as follows:

Funds relating to the conduct of human subject research
will be restricted until the appropriate assurances and Institutional
Review Board approvals are in place.

Reimbursement of pre-award costs is not allowed.

Grant funds will not be made available to support the
provision of direct care.

Eligible applicants may enter into contracts, including
consortia agreements, as necessary to meet the requirements of the program
and strengthen the overall application.

Travel expenses for the annual monitoring workshop in Atlanta should be included in the applicant’s proposed budget.)

6. Other Submission
Requirements

A detailed categorical budget for
the “Initial budget Period” and the “Entire Proposed Period of Support” must be
submitted with the application. If you are requesting indirect costs in your budget,
you must include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12 months of
age. If submitting electronically, use a PDF version of the agreement, attach
it in Grants.gov under “Other Attachments”, and title it appropriately.

Applicants’ research plan(s) should address activities they
will conduct over the entire project period.

The
HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the
“PROFILE – Project Director/Principal Investigator” section, “Credential”
log-in field of the “Research & Related Senior/Key Person Profile”
component. The applicant organization must include its DUNS number in its
Organizational Profile in the eRA Commons. This DUNS number must match the
DUNS number provided at CCR registration with Grants.gov. For additional
information, see Registration FAQs – Important Tips – Electronic Submission
of Grant Applications.

Research Plan Component
Sections

While each section of the
Research Plan component needs to be uploaded separately as a .pdf attachment,
applicants are encouraged to construct the Research Plan component as a single
document, separating sections into distinct .pdf attachments just before
uploading the files. This approach will enable applicants to better monitor
formatting requirements such as page limits. All attachments must be provided
to HHS/CDC in .pdf format, filenames must be included with no spaces or special characters, and a .pdf extension must be used. Do not
include any information in a header or footer of the attachments. A header will
be system-generated that references the PD/PI. Page numbers for the footer will
be system-generated in the complete application, with all pages sequentially
numbered; therefore, do not number the pages of your attachments. Your
research plan must not exceed 25 pages.
If your research plan exceeds the page limitation, your application may be
considered unresponsive and ineligible for review.

Up to 10publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly
relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and
specific Funding Opportunity Announcements (FOAs) to determine the appropriate
limit on the number of publications that may be submitted for a particular
program. Note that not all grant activity codes allow the inclusion of
publications.

Publications in press:
Include only a publication list with a link to the publicly available
on-line journal article or the NIH Pub Med Central (PMC) submission
identification number. Do not include the entire article.

Manuscripts accepted for
publication but not yet published: The entire article may be
submitted electronically as a .pdf attachment.

Manuscripts published but a
publicly available online journal link is not available: The
entire article may be submitted electronically as a .pdf attachment.

Graphic images of gels,
micrographs, etc. provided that the image (may be reduced in size) is also
included within the (stated) page limit of Items 2-5 of the Research Plan
component. No images may be included in the Appendix that are not
also represented within the Research Plan.

Please
note the following restriction on appendix attachments: The Research Plan Appendix
attachments are limited to 10 attachments. Appendices are uploaded as
attachments in the PHS 398 Research Plan form, in field #18, within the
electronic application package. An applicant will receive an error message if
the number of appendix attachments exceeds 10, which will result in an
unsuccessful submission of the application. You may include more than one
publication, or other allowable appendix material, within one attachment;
however, do not let your attachments exceed 10.

Do not use the Appendix to circumvent the page limitations of the
Research Plan component. An application that does not observe the relevant
policies and procedures may not be considered in the review process. Applicants
are reminded to review specific FOAs for any additional program-specific
guidance on Appendix material and other application requirements.

It is especially important that the abstract
(Description, SF424 form page 2) of your grant application reflect the
project’s focus; the abstract will be used to help determine the responsiveness
of the application. The following instructions supersede those provided in the
SF424 instructions. If your application is funded, your abstract will become
public information.

The abstract should be a 1 page document and
should contain the following sections:

Importance (One or two sentences explaining
the importance of the study question)

Objectives (Include specific aims and
hypotheses)

Study Design

Setting

Participants (Include the number of
participants and how they will be selected)

Interventions (Explain the essential features
of any interventions)

Outcome Measures

The language of the abstract must be simple and
easy to understand for a broad audience. For more information on how to write
an abstract please see the “Structured Abstracts” section at:
http://jama.ama-assn.org/ifora_current.dtl

Research Plan

You must include a research plan in your
application. The research plan should address activities to be conducted over
the entire project period. The research plan should include the following
information:

The project's focus, a justification for the
research proposed, and a description of the scientific basis for the research.
The focus should be based on recommendations in “Healthy People 2010"
(http://www.healthypeople.gov) and the “CDC Injury Research Agenda,”
(http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm) and should seek
creative approaches that will contribute to a national program for injury
control.

Specific, measurable, and time-framed
objectives.

A detailed plan describing the methods by
which the objectives will be achieved, including their sequence. A
comprehensive evaluation plan is an essential component of the application.

A description of the principal investigator's
role and responsibilities.

A description of those activities related to,
but not supported by, the grant.

A description of the involvement of other
entities that will relate to the proposed project, if applicable. It should
include commitments of support and a clear statement of their roles.

An explanation of how the research findings
will contribute to the national effort to reduce the morbidity, mortality and
disability caused by injuries within three to five years from project start-up.

Plan
for Sharing Research Data

Note: HHS/CDC normally requires a plan
for sharing research data. However, only proposals submitted to NCIPC for
individual research projects of $500,000 or more in total (direct and indirect)
costs per year require the applicant to include a data-sharing plan. Because
the ceiling for this FOA is below $500,000, a data sharing plan is not required
and the HHS/CDC steps outlined in this section do not apply.

Sharing Research Resources

Not applicable

Section V. Application Review Information

1.
Criteria

Only
the review criteria described below will be considered in the review process.

Scientific merit
of the proposed project as determined by peer review

Availability of
funds

Relevance of
program priorities and the priorities of the U.S. Department of Health and
Human Services

2.
Review and Selection Process

Applications
that are complete and responsive to the RFA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by NCIPC in accordance with the review criteria
stated below.

As part of the
initial merit review, all applications will:

Undergo a selection process in which only those
applications deemed to have the highest scientific merit, generally the
top half of applications under review, will be discussed and assigned a
priority score.

Receive a written critique.

Receive a second level of review by the Science and Program Review Subcommittee (SPRS) of
the Secretary’s Advisory Committee for Injury Prevention and Control
(ACIPC).

Applications submitted in response to this FOA
will compete for available funds with all other eligible applications.
The criteria listed in Section V.1. will be considered in making funding
decisions.

The goals of
HHS/CDC-supported research are to advance the understanding of health promotion
and the prevention of disease, injury, and disability, and enhance
preparedness. In the written comments, evaluate the application to judge the
likelihood the proposed research will have a substantial impact on the pursuit
of these goals. Each of these criteria will be addressed by the reviewers and
considered in assigning the overall score, weighting them as appropriate for
each application.

Significance

Approach

Innovation

Investigators

Environment

Note that an application does
not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.Significance: Does this study address an
important problem? If the applicant achieves the aims of the application, how
will it advance scientific knowledge or clinical practice? What will be the
effect of these studies on the concepts, methods, technologies, treatments, or
preventative interventions that drive this field?

Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics? For priority
one (dissemination/implementation research), has the applicant provided
documentation that the evidence-based intervention, program, or policy chosen
(in either the area of child maltreatment or youth violence) been previously
tested, evaluated, and demonstrated effective for the outcome of interest? For
priority two (efficacy/effectiveness research), does the research plan propose
to evaluate primary prevention of perpetration (in any of the following areas;
child maltreatment, intimate partner violence, sexual violence, youth violence,
and/or suicidal behavior) and focus on a target population that has not already
engaged in the perpetration of violence. For priority three (etiologic
research), does the applicant propose to examine the development of
perpetration and the populations at high risk for perpetration? Does the
project include plans to measure progress toward achieving the stated
objectives? Is there an appropriate work plan included?

Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?Does the
principal investigator have demonstrated experience conducting, evaluating, and
publishing violence prevention research as evidenced by publication of at least
one first-authored manuscript in violence prevention research in a
peer-reviewed journal or a current or previous research grant in the chosen
priority area?

Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?Is there an appropriate
degree of commitment and cooperation by other interested parties as evidenced
by letters of support detailing the nature and extent of their involvement?

2.A. Additional Review Criteria

In addition to
the above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:

Application Review

The primary review will be a peer review
conducted by HHS/CDC/NCIPC Initial Review Group (IRG). Applications may be
subjected to a preliminary evaluation (streamline review) by the IRG to
determine if the application is of sufficient technical and scientific merit to
warrant further review. HHS/CDC/NCIPC will withdraw from further consideration
applications judged to be noncompetitive and promptly notify the principal
investigator/program director and the official signing for the applicant
organization. Those applications judged to be competitive will be further
evaluated by the IRG. These applications will be reviewed for scientific merit using
current NIH criteria (a scoring system of 100 - 500 points) to evaluate the
methods and scientific quality of the application.

The secondary review will be conducted by the
current Science and Program Review Subcommittee (SPRS) of the Advisory Committee
for Injury Prevention and Control (ACIPC) or equivalent board of scientific
counselors. Only SPRS members will vote on funding recommendations, and their
recommendations will be carried to the entire ACIPC for voting by the ACIPC
members in closed session. If any further review is needed by the ACIPC
regarding the recommendations of the SPRS, the factors considered will be the
same as those considered by the SPRS.

The ACIPC Federal agency experts will be invited
to attend the secondary review and will receive modified briefing books (i.e.,
abstracts, strengths and weaknesses from summary statements, and extramural
research program office staff briefing materials). ACIPC Federal agency
experts will be encouraged to participate in deliberations when applications
address overlapping areas of research interest, so that unwarranted duplication
in federally-funded research can be avoided and special subject area expertise
can be shared. The HHS/CDC/NCIPC Division Associate Directors for Science
(ADS) or their designee will attend the secondary review to assist Extramural
Research Program Office staff to assure that research priorities of the
announcement are understood and to provide background regarding current
research priorities.

The ACIPC committee’s responsibility is to
develop funding recommendations for the HHS/CDC/NCIPC Director based on the
results of the primary review, the relevance and balance of proposed research
relative to the HHS/CDC/NCIPC programs and priorities, and to assure that unwarranted
duplication of federally-funded research does not occur. The secondary review
committee has the latitude to recommend to the HHS/CDC/NCIPC Director to reach
over better ranked proposals in order to assure maximum impact and balance of
proposed research. The factors to be considered will include:

The results of the primary review including the
application’s priority score as the primary factor in the selection process.

The relevance and balance of proposed research
relative to the HHS/CDC/NCIPC programs and priorities.

The significance of the
proposed activities in relation to the priorities and objectives stated in
“Healthy People 2010," the Institute of Medicine report, “Reducing
the Burden of Injury,” and the “CDC Injury Research Agenda.”

Budgetary considerations.

All awards will be determined by the Director of
the HHS/CDC/NCIPC based on priority scores assigned to applications by the
primary review committee IRG, recommendations by the secondary review committee
and the extramural research program staff, consultation with HHS/CDC/NCIPC
senior staff, and the availability of funds.

Continued Funding

Continuation awards made after FY 2008,
but within the project period, will be made on the basis of the availability of
funds and the following criteria:

The accomplishments reflected in the progress
report of the continuation application indicate that the applicant is meeting
previously stated objectives or milestones contained in the project’s annual
work plan and satisfactory progress is being demonstrated through presentations
at work-in-progress monitoring workshops (travel expenses for this annual
one-day meeting should be included in the applicant’s proposed budget).

The objectives for the new budget period are
realistic, specific, and measurable.

The methods described will clearly lead to
achievement of these objectives.

The evaluation plan will allow management to
monitor whether the methods are effective.

The budget request is clearly explained,
adequately justified, reasonable and consistent with the intended use of grant
funds.

Protection of Human Subjects from
Research Risk: When human subjects are involved, HHS/CDC will assess the available
protections from research risk that relate to their participation in the
proposed research [see the Research Plan, Section 2, item 8 on Human Subjects
in the SF424 (R&R)] located at, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are
available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Inclusion of Women and Minorities in
Research:

Does the
application adequately address the HHS/CDC Policy requirements regarding the
inclusion of women, ethnic, and racial groups in the proposed research? This
includes: (1) The proposed plan for the inclusion of both sexes and racial and
ethnic minority populations for appropriate representation; (2) The proposed
justification when representation is limited or absent; (3) A statement as to
whether the design of the study is adequate to measure differences when
warranted; and (4) A statement as to whether the plans for recruitment and
outreach for study participants include the process of establishing
partnerships with community(ies) and recognition of mutual benefits (see
Section 2, item 9 Inclusion or Women and Minorities of the Research Plan
component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If applicants plan to use
vertebrate animals in the project, HHS/CDC will assess the five items described
under Section 2, item 12 Vertebrate Animals of the Research Plan component of
the SF424 (R&R). Additional HHS/CDC Requirements under AR-3
Animal Subjects Requirements are available on the Internet at the following
address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Biohazards: If applicants propose the applicant has proposed
materials or procedures that are potentially hazardous to research personnel
and/or the environment, HHS/CDC will determine if the proposed protection is
adequate.

2.B. Additional Review Considerations

Budget and
Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. Is the number of person months
listed for the effort of the PD/PI appropriate for the work proposed? Is each
budget category realistic and justified in terms of the aims and methods? The
evaluation of the budget should not affect the priority score.

2.C. Sharing Research Data

Not applicable. Only proposals submitted to NCIPC for
individual research projects of $500,000 or more in total (direct and indirect)
costs per year require the applicant to include a data-sharing plan. Because
the ceiling for this FOA is below $500,000, a data sharing plan is not required.

2.D. Sharing Research Resources

Not
applicable

3. Anticipated
Announcement and Award Dates

Grantees will be notified in Septemberof 2008 by the
HHS/CDC’s Procurement and Grants Office (PGO) if their applications were
selected for funding.

Section VI. Award Administration Information

1.
Award Notices

After the peer
review of the application is completed, the applicant organization will receive
a written critique called a “Summary Statement.” The applicant organization
and the PD/PI will be able to access the Summary Statement via the eRA Commons.

HHS/CDC will contact those applicants under
consideration for funding for additional information.

A
formal notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the Grants Management Officer
(GMO) is the authorizing document. HHS/CDC will mail and/or e-mail this
document to the recipient fiscal officer identified in the application.

Selection
of the application for award is not an authorization to begin performance. Any
cost incurred before receipt of the NoA is at the recipient’s risk. These costs
may be reimbursed only to the extent considered allowable pre-award costs. See
also Section IV.5. Funding Restrictions.

2. Financial status
report, no more than 90 days after the end of the budget period.

3. Final financial
and performance reports, no more than 90 days after the end of the project
period.

Recipient
Organization must forward these reports by the U.S. Postal
Service or express delivery to the Grants Management Specialist listed in the
“Agency Contacts” section of this FOA.

Although
the financial plans of the HHS/CDC CIO(s) provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds, evidence of satisfactory progress by the recipient (as
documented in required reports) and the determination that continued funding is
in the best interest of the Federal government.

Section VII. Agency Contacts

HHS/CDC encourages your inquiries concerning this FOA and welcomes
the opportunity to answer questions from potential applicants. Inquiries can
fall into three areas: scientific/research, peer review, and financial or
grants management issues:

NCIPC Website: For additional help in preparing
your grant application please see the “frequently asked questions” section on
the NCIPC webpage at: http://www.cdc.gov/ncipc.

Conference Call

Technical assistance
will be available for potential applicants during one conference call. The call
for eligible applicants will be held on January 15, 2008 from 9:30 a.m. to
11:00 a.m. (Eastern Time). The conference can be accessed by calling:
1-866-704-7564, stating the leader name: Ms Lady Patterson, and entering the
passcode: 1314492.

Participation in this
conference call is not mandatory.

At the time of the call,
if you have problems accessing the conference call, please call 770-488-1044
for assistance.

Section VIII. Other Information

Required
Federal Citations

Human
Subjects Protection:Federal
regulations (45 CFR Part 46) require that applications and proposals involving
human subjects must be evaluated with reference to the risks to the subjects,
the adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). Additional HHS/CDC Requirements under AR-1 Human Subjects
Requirements can be found on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Requirements
for Inclusion of Women and Racial and Ethnic Minorities in ResearchIt
is the policy of the Centers for Disease Control and Prevention (CDC) and the
Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that
individuals of both sexes and the various racial and ethnic groups will be
included in CDC/ATSDR-supported research projects involving human subjects,
whenever feasible and appropriate. Racial and ethnic groups are those defined
in OMB Directive No. 15 and include American Indian or Alaska Native, Asian,
Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific
Islander. Applicants shall ensure that women, racial and ethnic minority
populations are appropriately represented in applications for research
involving human subjects. Where clear and compelling rationale exist that
inclusion is inappropriate or not feasible, this situation must be explained as
part of the application. This policy does not apply to research studies when
the investigator cannot control the race, ethnicity, and/or sex of subjects.
Further guidance to this policy is contained in the Federal Register, Vol. 60,
No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must be included in all
human subjects research that is conducted or supported by CDC, unless there are
scientific and ethical reasons not to include them. This policy applies to all
CDC-conducted or CDC-supported research involving human subjects, including
research that is otherwise exempt in accordance with Sections 101(b) and 401(b)
of 45 C.F.R.
Part 46, HHS Policy for the Protection of Human Subjects. Therefore,
proposals for research involving human subjects must include a description of
plans for including persons under the age of 21. If persons under the age of 21
will be excluded from the research, the application or proposal must present an
acceptable justification for the exclusion.

In an extramural research plan, the investigator should create a section
titled "Participation of persons under the age of 21." This section
should provide either a description of the plans to include persons under the
age of 21 and a rationale for selecting or excluding a specific age range, or
an explanation of the reason(s) for excluding persons under the age of 21 as
participants in the research. When persons under the age of 21 are included,
the plan must also include a description of the expertise of the investigative
team for dealing with individuals at the ages included, the appropriateness of
the available facilities to accommodate the included age groups, and the
inclusion of a sufficient number of persons under the age of 21 to contribute
to a meaningful analysis relative to the purpose of the study. Scientific
review groups at CDC will assess each application as being acceptable or
unacceptable in regard to the age-appropriate inclusion or exclusion of persons
under the age of 21 in the research project, in addition to evaluating the
plans for conducting the research in accordance with these provisions.

The inclusion of children (as defined by the applicable law of the
jurisdiction in which the research will be conducted) as subjects in research
must be in compliance with all applicable subparts of 45 C.F.R.
Part 46, as well as with other pertinent federal laws and
regulations.

The policy of inclusion of persons under the age of 21 in CDC-conducted
or CDC-supported research activities in foreign countries (including
collaborative activities) is the same as that for research conducted in the
United States.

Public Health System Reporting RequirementsThis program is subject to the Public Health System
Reporting Requirements. Under these requirements, all community-based
non-governmental organizations submitting health services applications must
prepare and submit the items identified below to the head of the appropriate
State and/or local health agency(s) in the program area(s) that may be impacted
by the proposed project no later than the application deadline date of the
Federal application. The appropriate State and/or local health agency is
determined by the applicant. The following information must be provided:

A. A copy of the face page of
the application (SF 424).

B. A summary of
the project that should be titled "Public Health System Impact
Statement" (PHSIS), not exceed one page, and include the following:

1. A
description of the population to be served.

2. A
summary of the services to be provided.

3. A
description of the coordination plans with the appropriate state and/or local
health agencies.

If the State and/or local health official should
desire a copy of the entire application, it may be obtained from the State
Single Point of Contact (SPOC) or directly from the applicant.

Paperwork Reduction Act Requirements

Under the Paperwork Reduction
Act, projects that involve the collection of information from 10 or more
individuals and funded by a grant or a cooperative agreement will be subject to
review and approval by the Office of Management and Budget (OMB).

Smoke-Free Workplace
Requirements

CDC strongly encourages all recipients to provide a
smoke-free workplace and to promote abstinence from all tobacco products.
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities that receive Federal funds in which education, library, day care,
health care, or early childhood development services are provided to children.

Healthy People 2010

The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This PA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at www.healthypeople.gov.

Lobbying
Restrictions

Applicants should be aware of restrictions on the use
of HHS funds for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier
contractors) are prohibited from using appropriated Federal funds (other than
profits from a Federal contract) for lobbying congress or any Federal agency in
connection with the award of a particular contract, grant, cooperative
agreement, or loan. This includes grants/cooperative agreements that, in whole
or in part, involve conferences for which Federal funds cannot be used directly
or indirectly to encourage participants to lobby or to instruct participants on
how to lobby.

In
addition no part of CDC appropriated funds, shall be used, other than for
normal and recognized executive-legislative relationships, for publicity or
propaganda purposes, for the preparation, distribution, or use of any kit,
pamphlet, booklet, publication, radio, television, or video presentation
designed to support or defeat legislation pending before the Congress or any
State or local legislature, except in presentation to the Congress or any State
or local legislature itself. No part of the appropriated funds shall be used to
pay the salary or expenses of any grant or contract recipient, or agent acting
for such recipient, related to any activity designed to influence legislation
or appropriations pending before the Congress or any State or local
legislature.

Any activity designed to influence action in regard to
a particular piece of pending legislation would be considered
"lobbying." That is lobbying for or against pending legislation, as
well as indirect or "grass roots" lobbying efforts by award
recipients that are directed at inducing members of the public to contact their
elected representatives at the Federal or State levels to urge support of, or
opposition to, pending legislative proposals is prohibited. As a matter of
policy, HHS/CDC extends the prohibitions to lobbying with respect to local
legislation and local legislative bodies.

The provisions are not intended to prohibit all
interaction with the legislative branch, or to prohibit educational efforts
pertaining to public health. Clearly there are circumstances when it is
advisable and permissible to provide information to the legislative branch in
order to foster implementation of prevention strategies to promote public
health. However, it would not be permissible to influence, directly or
indirectly, a specific piece of pending legislation

It remains permissible to use HHS/CDC funds to engage
in activity to enhance prevention; collect and analyze data; publish and
disseminate results of research and surveillance data; implement prevention
strategies; conduct community outreach services; provide leadership and
training, and foster safe and healthful environments.

Recipients of HHS/CDC grants and cooperative
agreements need to be careful to prevent CDC funds from being used to influence
or promote pending legislation. With respect to conferences, public events,
publications, and "grassroots" activities that relate to specific
legislation, recipients of HHS/CDC funds should give close attention to
isolating and separating the appropriate use of HHS/CDC funds from non-CDC
funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to
give the appearance that HHS/CDC funds are being used to carry out activities
in a manner that is prohibited under Federal law.

Prohibition on Use of CDC
Funds for Certain Gun Control Activities

The Departments of Labor, Health and Human Services,
and Education, and Related Agencies Appropriations Act specifies that:
"None of the funds made available for injury prevention and control at the
Centers for Disease Control and Prevention may be used to advocate or promote
gun control."

Anti-Lobbying Act requirements prohibit lobbying
Congress with appropriated Federal monies. Specifically, this Act prohibits the
use of Federal funds for direct or indirect communications intended or designed
to influence a member of Congress with regard to specific Federal legislation.
This prohibition includes the funding and assistance of public grassroots campaigns
intended or designed to influence members of Congress with regard to specific
legislation or appropriation by Congress.

In addition to the restrictions in the Anti-Lobbying
Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean
that HHS/CDC's funds may not be spent on political action or other activities
designed to affect the passage of specific Federal, State, or local legislation
intended to restrict or control the purchase or use of firearms.

Accounting System
Requirements

The services of a certified public accountant licensed
by the State Board of Accountancy or the equivalent must be retained throughout
the project as a part of the recipient's staff or as a consultant to the
recipient's accounting personnel. These services may include the design,
implementation, and maintenance of an accounting system that will record
receipts and expenditures of Federal funds in accordance with accounting
principles, Federal regulations, and terms of the cooperative agreement or
grant.

Capability Assessment

It may be necessary to conduct an on-site evaluation
of some applicant organization's financial management capabilities prior to or
immediately following the award of the grant or cooperative agreement.
Independent audit statements from a Certified Public Accountant (CPA) for the
preceding two fiscal years may also be required.

Proof of Non-profit Status

Proof of nonprofit status must be submitted by private
nonprofit organizations with the application. Any of the following is acceptable
evidence of nonprofit status: (a) a reference to the applicant organization's
listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt
organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a
currently valid IRS tax exemption certificate; (c) a statement from a State
taxing body, State Attorney General, or other appropriate State Official
certifying that the applicant organization has a nonprofit status and that none
of the net earnings accrue to any private shareholders or individuals; (d) a
certified copy of the organization's certificate of incorporation or similar
document that clearly establishes nonprofit status; (e) any of the above proof
for a State or national parent organization and a statement signed by the
parent organization that the applicant organization is a local nonprofit
affiliate.

Security
Clearance Requirement

All individuals who will be performing work under a
grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site
facility) must receive a favorable security clearance, and meet all security
requirements. This means that all awardee employees, fellows, visiting
researchers, interns, etc., no matter the duration of their stay at HHS/CDC
must undergo a security clearance process.

Small, Minority, And
Women-owned Business

It is a national policy to place a fair share of
purchases with small, minority and women-owned business firms. The Department
of Health and Human Services is strongly committed to the objective of this policy
and encourages all recipients of its grants and cooperative agreements to take
affirmative steps to ensure such fairness. In particular, recipients should:

Place small, minority, women-owned business firms
on bidders mailing lists.

Solicit these firms whenever they are potential
sources of supplies, equipment, construction, or services.

Where feasible, divide total requirements into
smaller needs, and set delivery schedules that will encourage
participation by these firms.

Use the assistance of the Minority Business
Development Agency of the Department of Commerce, the Office of Small and
Disadvantaged Business Utilization, DHHS, and similar state and local
offices.

Research Integrity

The signature of the institution
official on the face page of the application submitted under this Funding
Opportunity Announcement is certifying compliance with the Department of Health
and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E,
entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

Section 93.301 Institutional assurances. (a) General policy.
An institution with PHS supported biomedical or behavioral research, research
training or activities related to that research or research training must
provide PHS with an assurance of compliance with this part, satisfactory to the
Secretary. PHS funding components may authorize [[Page 28389]] funds for
biomedical and behavioral research, research training, or activities related to
that research or research training only to institutions that have approved
assurances and required renewals on file with ORI. (b) Institutional Assurance.
The responsible institutional official must assure on behalf of the institution
that the institution-- (1) Has written policies and procedures in compliance
with this part for inquiring into and investigating allegations of research
misconduct; and (2) Complies with its own policies and procedures and the
requirements of this part.

Compliance
with Executive Order 13279

Faith-based organization are
eligible to receive federal financial assistance, and their applications are
evaluated in the same manner and using the same criteria as those for
non-faith-based organizations in accordance with Executive Order 13279, Equal
Protection of the Laws for Faith-Based and Community Organizations. All
applicants should, however, be aware of restrictions on the use of direct
financial assistance from the Department of Health and Human Services (DHHS)
for inherently religious activities. Under the provisions of Title 45, Parts
74, 87, 92 and 96, organizations that receive direct financial assistance from
DHHS under any DHHS program may not engage in inherently religious activities,
such as worship, religious instruction, or proselytization as a part of the
programs or services funded with direct financial assistance from DHHS. If an
organization engages in such activities, it must offer them separately, in time
or location, from the programs or services funded with direct DHHS assistance,
and participation must be voluntary for the beneficiaries of the programs or
services funded with such assistance. A religious organization that
participates in the DHHS funded programs or services will retain its
independence from Federal, State, and local governments, and may continue to
carry out its mission, including the definition, practice, and expression of
its religious beliefs, provided that it does not use direct financial
assistance from DHHS to support inherently religious activities such as those
activities described above. A faith-based organization may, however, use space
in its facilities to provide programs or services funded with financial
assistance from DHHS without removing religious art, icons, scriptures, or
other religious symbols. In addition, a religious organization that receives
financial assistance from DHHS retains its authority over its internal
governance, and it may retain religious terms in its organization=s name, select its board
members on a religious basis, and include religious references in its
organization=s mission statements and other governing documents in
accordance with all program requirements, statutes, and other applicable
requirements governing the conduct of DHHS funded activities. For further
guidance on the use of DHHS direct financial assistance see Title 45, Code of
Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations,
and visit the internet site:http://www.whitehouse.gov/government/fbci/

Health Insurance Portability and Accountability Act
Requirements

Recipients of this grant award should note that
pursuant to the Standards for Privacy of Individually Identifiable Health
Information promulgated under the Health Insurance Portability and
Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may
disclose protected health information to public health authorities authorized
by law to collect or receive such information for the purpose of preventing or
controlling disease, injury, or disability, including, but not limited to, the
reporting of disease, injury, vital events such as birth or death, and the
conduct of public health surveillance, public health investigations, and public
health interventions. The definition of a public health authority includes a
person or entity acting under a grant of authority from or contract with such
public agency. HHS/CDC considers this project a public health activity
consistent with the Standards for Privacy of Individually Identifiable Health
Information and CDC will provide successful recipients a specific grant of
public health authority for the purposes of this project.

Release and Sharing of Data

The Data Release Plan is the Grantee's assurance that
the dissemination of any and all data collected under the CDC data sharing
agreement will be released as follows:

When required (see note below) applications must include a copy of the
applicant's Data Release Plan. Applicants should provide CDC with
appropriate documentation on the reliability of the data. Applications
submitted without the required Plan may be ineligible for award. Award
will be made when reviewing officials have approved an acceptable Plan.
The successful applicant and the Program Manager will determine the
documentation format. HHS/CDC recommends data is released in the form
closest to micro data and one that will preserve confidentiality.

Note: Only
proposals submitted to NCIPC for individual research projects of $500,000 or
more in total (direct and indirect) costs per year require the applicant to
include a data-sharing plan. Because the ceiling for this FOA is below
$500,000, a data sharing plan is not required.

National Historic
Preservation Act of 1966

(Public Law 89-665, 80
Stat. 915)

The grantee’s signature on
the grant application attests to their: (1) knowledge of the National Historic
Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to
ensure all grant related activities are in compliance with referenced public
law, as stated:

The
head of any Federal agency, having direct or indirect jurisdiction over a
proposed Federal or Federally assisted undertaking in any State and the head of
any Federal department or independent state agency having authority to license
any undertaking, shall, prior to the approval of the expenditure of any
Federal funds on the undertaking or prior to the issuance of any license, as
the case may be, take into account the effect of the undertaking on any
district, site, building, structure, or object that is included in or is
eligible for inclusion in the National Register. The head of any such Federal
agency shall afford the Advisory Council on Historic Preservation established
under Title II of this ACT a reasonable opportunity to comment with regard to
such undertaking.

b. Additionally,
the NHPA also contains the following excerpt that forbids “anticipatory
demolition:”

Each
Federal agency shall ensure that the agency will not grant a loan, loan
guarantee, permit, license, or other assistance to an applicant who, with
intent to avoid the requirements of Section 106 of this Act, has intentionally,
significantly, adversely affected a historic property to which the grant would
relate or, having legal power to prevent it, allowed such significant adverse
effect to occur, unless the agency, after consultation with the Council,
determines that circumstances justify granting such assistance despite the adverse
effect created or permitted by the applicant.

Conference Disclaimer and Use of
Logos

Disclaimer: Where a conference is funded by a grant or cooperative
agreement, a subgrant or a contract the recipient must include the following
statement on conference materials, including promotional materials, agenda, and
internet sites:

“Funding for this conference was made possible [in part] by
[insert grant or cooperative agreement award number] from the Centers for
Disease Control and Prevention(CDC) or the Agency for Toxic Substances and
Disease Registry (ATSDR) . The views expressed in written conference materials
or publications and by speakers and moderators do not necessarily reflect the
official policies of the Department of Health and Human Services; nor does
mention of trade names, commercial practices, or organizations imply
endorsement by the U.S. Government.”

Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be
displayed if such display would cause confusion as to the source of the conference
or give the false appearance of Government endorsement. A non-federal entity’s
unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10,
which prohibits the misuse of the HHS name and emblem in written communication.
The appropriate use of the HHS logo is subject to the review and approval of
the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the
Office of the Inspector General has authority to impose civil monetary
penalties for violations (42 C.F.R. Part 1003). Neither the HHS nor the CDC
logo can be used on conference materials under a grant, cooperative agreement,
contract or co-sponsorship agreement without the expressed, written consent of
either the Project Officer or the Grants Management Officer. It is the
responsibility of the grantee (or recipient of funds under a cooperative
agreement) to request consent for the use of the logo in sufficient detail to
assure a complete depiction and disclosure of all uses of the Government logos,
and to assure that in all cases of the use of Government logos, the written
consent of either the Project Officer or the Grants Management Officer has been
received.